A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers.

A Single-blind, Placebo Controlled, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3389934 Intravenous Infusions in Healthy Japanese Participants.

A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers. (NCT07176728) is a Phase 1 interventional studying Sepsis Associated Disseminated Intravascular Coagulation (DIC), sponsored by Bayer. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study is designed to evaluate a new investigational drug, BAY 3389934, in healthy Japanese volunteers. The primary purpose is to see how safe the drug is and how well it is tolerated by the body when given at different doses. BAY 3389934 is being developed for the potential treatment of a serious blood clotting condition called sepsis-associated disseminated intravascular coagulation (DIC). The research will be conducted as a single-blind, placebo-controlled, dose-escalation study. This means that participants will be randomly assigned to receive either the active drug (BAY 3389934) or a placebo (an inactive substance), and they will not know which one they are receiving. The study will involve up to 16 healthy male and female Japanese participants, aged between 18 and 55. The study consists of two parts, called dose steps. In the first step, participants will receive a single 4-hour intravenous (IV) infusion of BAY 3389934 at a dose of 15 mg/h, or a placebo. Based on the safety and tolerability results from this first step, a second, higher dose will be selected for the next group of participants in the second step. Throughout the study, researchers will closely monitor participants for any side effects (adverse events). They will also collect blood and urine samples to study how the drug is absorbed, distributed, and eliminated by the body (pharmacokinetics or PK) and what effects it has on the body's clotting system (pharmacodynamics or PD). This involves measuring specific substances in the blood, such as activated partial thromboplastin time (aPTT) and prothrombin time (PT). Participants will stay at the study center for 4 days and will have a follow-up visit 3 to 5 days after they are discharged. The information gathered from this study is crucial for the future clinical development of BAY 3389934 in Japan and for designing future studies in patients with septic DIC.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Sepsis Associated Disseminated Intravascular Coagulation (DIC), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 16 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Participant must be 18 to 55 years of age inclusive. - Participants who are overtly healthy Japanese as determined by medical evaluation. - Body mass index (BMI) within the range 18 - 29.9 kg/m² (inclusive). - Male participants must agree to use specified contraception during the study and for at least 90 days plus 5 half-lives after. - Female participants must be a Woman of Nonchildbearing Potential (WONCBP). - Capable of giving signed willing to sign a consent form. - Willing to comply with the requirements and restrictions listed in the protocol. Who Should NOT Join This Trial: - Any medical disorder, condition, or history that would impair participation. - Known hypersensitivity to the study drug or its excipients. - Known disorders with increased bleeding risk or known congenital/acquired coagulation disorders. - Use of prescription drugs, over-the-counter drugs, or herbal products within 14 days or 5 half-lives before the study. - Clinically relevant findings in the ECG, such as a QTcF over 450 msec. - Systolic blood pressure below 90 mmHg or above 140 mmHg at screening and admission. - Diastolic blood pressure below 40 mmHg or above 90 mmHg at screening and admission. - Positive results for Hepatitis B, Hepatitis C, or HIV. - Positive drug screening, alcohol breath test, or urine cotinine test. - Clinically relevant deviations of the screened laboratory parameters from reference ranges at the screening visit. - Positive pregnancy test. - Donation of blood or plasma within specified timeframes before the study. - Lack of compliance with lifestyle restrictions (e.g., alcohol, specific foods, strenuous activity). - Previous participation in this or another clinical study within a specified timeframe. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive. * Participants who are overtly healthy Japanese as determined by medical evaluation. * Body mass index (BMI) within the range 18 - 29.9 kg/m² (inclusive). * Male participants must agree to use specified contraception during the study and for at least 90 days plus 5 half-lives after. * Female participants must be a Woman of Nonchildbearing Potential (WONCBP). * Capable of giving signed informed consent. * Willing to comply with the requirements and restrictions listed in the protocol. Exclusion Criteria: * Any medical disorder, condition, or history that would impair participation. * Known hypersensitivity to the study drug or its excipients. * Known disorders with increased bleeding risk or known congenital/acquired coagulation disorders. * Use of prescription drugs, over-the-counter drugs, or herbal products within 14 days or 5 half-lives before the study. * Clinically relevant findings in the ECG, such as a QTcF over 450 msec. * Systolic blood pressure below 90 mmHg or above 140 mmHg at screening and admission. * Diastolic blood pressure below 40 mmHg or above 90 mmHg at screening and admission. * Positive results for Hepatitis B, Hepatitis C, or HIV. * Positive drug screening, alcohol breath test, or urine cotinine test. * Clinically relevant deviations of the screened laboratory parameters from reference ranges at the screening visit. * Positive pregnancy test. * Donation of blood or plasma within specified timeframes before the study. * Lack of compliance with lifestyle restrictions (e.g., alcohol, specific foods, strenuous activity). * Previous participation in this or another clinical study within a specified timeframe.

Treatments Being Tested

DRUG

BAY 3389934

Solution for intravenous infusion

DRUG

Matching Placebo / Diluent

Solution for intravenous infusion

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

SOUSEIKAI Fukuoka Mirai Hospital

Fukuoka, Fukuoka Pref, Japan

SOUSEIKAI Fukuoka Mirai Hospital

Fukuoka, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07176728), the sponsor (Bayer), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07176728 clinical trial studying?

Who can participate in NCT07176728?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07176728?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07176728. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07176728. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.